Annulotomy closure device

ABSTRACT

A system for sealing a hole in a body, comprising a generally cylindrical mesh formed from a plurality of helical strands which is inserted into the hole, with at least one end of the cylindrical mesh being moved least partially through an interior portion of the cylindrical shaped mesh such that the mesh expands radially outwards against sides of the hole.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation application claiming priorityfrom Provisional U.S. Patent Application No. 60/154,969 filed Sep. 20,1999, which is incorporated herein by reference in its entirety for allpurposes.

TECHNICAL FIELD

The present invention relates to systems for sealing holes in body partsand to sealing surgically formed holes in a bony structure in generaland in particular to systems for providing closure of a surgical accesshole in an intervertebral disc following an annulotomy.

BACKGROUND OF THE INVENTION

Each intervertebral disc has a firm outer layer, called the annulusfibrosus, and a gelatinous interior called the nucleus pulposus. Theannulus fibrosus acts as a semi-rigid elastic pressure vessel to containthe nucleus pulposus, therefore creating a compliant interface betweenthe relatively rigid vertebrae above and below each disc. Adjacent toeach disc, a pair of nerve roots pass from the spinal canal throughapertures called intervertebral foramen on each side of the spine. Dueto the location of the nerve roots, they are vulnerable to pressure froma herniated disc. In certain instances, the herniated section of theannulus fibrosus may become thinner through the transverse plane of thedisc.

When a partial intervertebral discectomy is performed, the offendingportion of the herniated disc is excised. In this procedure, the surgeonmust first make an appropriate incision through the skin and othertissue layers, and then typically create an access hole into theherniated annulus (an annulotomy) to treat the offending tissue. Suchaccess holes are created with a variety of surgical instrumentsincluding scalpels, probes, trephines, etc., and the access hole mayrange in size from 3 to 6 mm in diameter. Furthermore, as instrumentsare passed through the circular hole, the hole may become enlarged orelongated in nature upon completion of the procedure. Upon entry to theinterior annular space, the offending tissue is then manipulated and/orremoved by the surgeon. In current practice, the surgeon closes theouter wounds created by the procedure, but leaves the access hole open.Due to the semi-rigid nature of the annular tissue, closure by means oftraditional tissue approximation techniques, such as suturing, is nearlyimpossible. Closure is further complicated by the proximity of nervesand the depth of the access hole below the surface of the skin. As acomplication of disc excision surgery, such annular defects canrepresent a potential liability with respect to subsequent recurrentdisc herniations. This is due to the fact that the annular defectbetween the interior space of the annulus and the area adjacent to theannulotomy allows for possible future passage of nucleus pulposus tissuetherethrough. During the course of normal movement by the patient duringthe post operative healing phase, (which may last up to several weeks),relatively high fluidic pressures can be generated within the annularspace. These high pressures can cause the nucleus pulposus to beextruded through the open hole and impinge upon nearby nerves, thuscausing a reoccurrence of the original symptoms that the surgeonintended to treat.

SUMMARY OF THE INVENTION

The present invention provides methods and apparatus for the closure ofholes, including surgical access holes formed in a rigid or semi-rigidbody, and is particularly useful in closing a surgical access hole in anintervertebral disc. As such, the present invention provides systems ofannulotomy closure which reduce the risks of reherniation.

In a first aspect of the invention, a system comprising a generallycylindrical-shaped mesh is used to seal a hole which may be a surgicalaccess hole. The mesh itself may preferably comprise a braid of separatestrands with each strand following a helical path around a centrallongitudinal axis such that the mesh comprises a flexible tube ofinterwoven springs. In various optional aspects, at least one of theproximal (i.e.: outer surface) and distal (i.e.: deep) ends of thecylindrical-shaped mesh may optionally be covered by an end-cap whichmay be made of the mesh material.

In this first aspect of the invention, the mesh cylinder may first beinserted into the hole in the annulus and positioned such that both theproximal and distal ends of the mesh extend somewhat out of therespective proximal and distal ends of the hole. Thereafter, theproximal end of the mesh can be pushed longitudinally in a distaldirection through the “interior” of the mesh (ie: through the centraltube defined by the cylindrically-shaped mesh body) to a distance suchthat the proximal end may pass fully through the interior of the mesh,and extend in a distal direction at least partially past the distal endof the mesh. This causes the mesh cylinder to become folded over uponitself, with one end of the mesh being folded into the center of themesh.

In further aspects, the distal end of the cylindrical-shaped mesh may bepulled in a proximal direction such that a region of the mesh adjacentthe distal end expands radially outwards, bulging around the inner(distal) perimeter of the distal end of the hole. Furthermore, theproximal end of the cylindrical mesh can be pushed in a distal directionsuch that a portion of the mesh adjacent the proximal end of the holeexpands radially outwards, bulging around the outer (proximal) perimeterof the hole.

The present invention also provides a method of sealing a hole in a bodypart, comprising introducing a generally cylindrical shaped mesh intothe hole and then moving at least one end of the cylindrical shaped meshat least partially through an interior portion of the cylindrical shapedmesh such that the mesh expands radially outwards against sides of thehole.

The pushing of the proximal end in a distal direction and/or the pullingof the distal end in a proximal direction will preferably tend to causethe cylindrical shaped mesh to expand radially outwards, thereby firmlyanchoring the mesh against the walls of the hole in the annulus.

In further preferred aspects, the proximal and distal ends of thecylindrical mesh can be formed to be of a fixed diameter such as by theattachment or formation of a non-expandable ring thereon.

A plurality of suture/tethers may optionally be attached to the distalend of the mesh to pull it in a proximal direction. Tubular insertersfor positioning the cylindrical mesh within the bore of the hole mayalso be provided.

In various aspects, the diameter of one end of the mesh is constructedto be smaller than that of the other end of the mesh such that a firstend can easily be pulled through a second end of the mesh. In specificpreferred aspects, the diameter of the proximal end will be smaller thanthat of the distal end.

In an alternate method of employing the present invention, each of theproximal and distal ends of the cylindrical mesh may be pulled partiallyinto the center of the cylindrical mesh (ie: pulled partially throughthe interior tube defined by the mesh body) such that the proximal endis moved distally and the distal end is moved proximally, towards, oroptionally passing through, one another.

In a second aspect of the invention, various systems for sealing asurgically cut hole in the disc are provided comprising a generallyplanar sheet-like material which is cut or formed into a circularpattern having a plurality of radially extending “flower petal”-typeextensions. These petals are first bent radially inwards giving thestructure a generally conical shape. The petals will then tend to flexradially outwards when released after the device has been place into thehole in the annulus, thereby sealing the hole. Specifically, theresultant conical structure of the second aspect of the invention isinserted longitudinally into the hole in the annulus and is thenreleased such that the petals will tend to flex radially outwards,thereby anchoring the structure in position in the hole. In this aspectof the invention, the spaces cut between successive radially extendingpetals may be adapted to permit some fluid movement therethrough. Invarious designs of this aspect of the invention, a plurality of suchsheet-like “flower petal” structures are bent into a conical shape andare inserted in succession into the hole.

Advantages of both aspects of the present invention include itsencouragement of rapid healing by providing a lattice structure toenhance tissue growth. Moreover, the present annulotomy closure systemsare also able to accommodate the various sizes and geometries of annularholes that may be encountered by the surgeon. Furthermore, the presentannulotomy closure systems all provide compensation for normal movementduring patient healing since the system itself remains transverselyflexible but is positionally stable along its longitudinal axis. Afurther advantage of the present system is that should any portion ofthe mesh remain on the outside of the hole on the annulus, this would beatraumatic to adjacent nerves in close proximity to the device due tothe soft and flexible nature of the mesh material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a cylindrical shaped mesh.

FIG. 2 is a sectional side elevation view of the cylindrical mesh ofFIG. 1 positioned in a hole in the annulus of an intervertebral disc.

FIG. 3 is a sectional side elevation view of a tubular shaped mesh.

FIG. 4 is a sectional side elevation view of the mesh of FIG. 3 receivedthrough a hole in an intervertebral disc.

FIG. 5 is the system of FIG. 4 after the distal end of the mesh has beenpulled in a proximal direction, causing a portion of the mesh to expandaround the inner surface of the hole.

FIG. 6 shows the system of FIG. 4 after the proximal end of the mesh hasbeen pushed in a distal direction, causing a portion of the mesh toexpand around the outer surface of the hole.

FIG. 7 shows the system of FIG. 6 after the proximal end of the mesh hasbeen pushed distally through the distal end of the mesh.

FIG. 8 is a perspective view of a system for delivering the tubular meshillustrated in FIGS. 3 to 7.

FIG. 9 is a sectional side elevation view of the mesh of FIG. 1 in afirst position.

FIG. 10 is a sectional side elevation view of the mesh of FIG. 1 in asecond position.

FIG. 11 is a perspective view of an alternate aspect of the firstembodiment of the present invention.

FIG. 12A is a sectional side elevation view of the system of FIG. 11positioned in the annular hole.

FIG. 12B is a side elevation view corresponding to FIG. 12A, but withthe system distally advanced into the hole.

FIG. 13A is a front elevation view of a second aspect of the presentinvention.

FIG. 13B is a side elevation view of the device of FIG. 13A.

FIG. 14 is a side elevation view of the system of FIGS. 13A and 13Bdeformed into a conical shape and inserted into a surgical access holein an intervertebral disc.

FIG. 15 is a front view of different designs for the second aspect ofthe present invention shown in FIGS. 13A and 13B.

FIG. 16 is a side elevation view of a plurality of devices asillustrated in FIGS. 13A, 13B or 15 deformed into conical shapes andinserted into a surgical access hole in an intervertebral disc.

FIG. 17 corresponds to FIG. 16 but illustrates the apexes of the conicalshapes pointing in opposite directions.

FIG. 18 is a side elevation view of a pair of systems as illustrated inFIGS. 13A, 13B or 15 for insertion into a surgical access hole inoppositely facing directions.

FIG. 19 shows a side view of the system arrangement of FIG. 18, but withthe conical shaped structures deformed into an inverted position.

FIG. 20 shows a side view and an enlarged close-up view of the conicalshaped structures of FIGS. 18 and 19 interlocked together.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention provides methods and apparatus for sealing holesin various bony structures. In a preferred aspect, the present inventionprovides methods and apparatus for sealing a surgical hole drilled in apatient's annulus. As such, the present invention is ideally suited toseal a hole drilled in an intervertebral disc such that nucleus pulposuson the inside of the disc cannot seep or flow through the hole to theoutside of the disc as the disc is compressed during normal movement.The present system is not limited only to sealing holes which have beendrilled in an annulus, but may also be used to seal naturally occurringholes as well. Moreover, the present invention is not limited to sealingholes in the annulus alone but may be used to seal any hole, therebyinhibiting the passage of soft tissue therethrough.

FIG. 1 shows a generally cylindrical tubular mesh which is comprised ofa, multiplicity of monofillament or multifilliar strands 13 ofsuture-type material, each following a helical path about centrallongitudinal axis A. Mesh 10 has a proximal end 12 and a distal end 14.An advantageous property of mesh 10 is that as proximal end 12 anddistal end 14 are moved closer together with respect to one another,mesh 10 will tend to expand radially outwards, widening in its diameterD.

In a preferred design, the mesh diameter D is approximately 1 to 8,millimeters, and more preferably about 3 millimeters when mesh 10 is inits relaxed state, (i.e.: when ends 12 and 14 are not being pushedtogether). When ends 12 and 14 are pushed together, however, diameter Dof mesh 10 may reach 9 millimeters. In preferred designs, strands 13 mayeach be made of 0.15 millimeter polypropylene sutures. Other materialshaving suitable dimensions, bioabsorption, strength, spring rate orradiopacity may also be used.

In an optional aspect, proximal end 12 may be sealed, for example with amesh closure positioned thereover. In another optional aspect of theinvention, as will be explained, ends 12 and 14 may be formed to benon-expandable such that their diameters do not change as ends 12 and 14of mesh 10 are pushed together relative to one another. For example, asolid ring may be formed at, or attached to, one or both of ends 12 and14.

FIG. 2 illustrates a preferred method of operating the presentinvention, as follows. Mesh 10 is inserted longitudinally in distaldirection D into surgically cut hole 21 in disc 20 such that proximalend 12 and distal end 14 extend out of hole 21 past outer surface 11 andinner surface 13 of hole 21 in disc 20 as defined by walls 22 as shown.

As is shown in FIG. 3, mesh 10 may optionally be fitted with a pluralityof sutures/tethers 30 which are tied to the distal end 14 of mesh 10 andextend through the central chamber of mesh 10 as shown.

As shown in FIG. 4, mesh 10 is inserted in a distal direction D suchthat it is positioned in hole 21 with its distal end 14 extending pastinner surface 13 of disc 20, and with its proximal end 12 extending pastouter surface 111 of disc 20. The placement of distal end 14 at anappropriate distal depth such that a portion of mesh 10 extends in aproximal direction from outer surface 11 of hole 21 can be enhancedthrough various visualization techniques such as shaft depth markers orendoscopic, radiographic or ultrasound methods.

For clarity of illustration, to show both the side walls of hole 21 andmesh 10, the following Figs. show a small clearance between the walls ofthe mesh and the walls of the hole when the mesh has been expanded intoposition, (for example, by pushing proximal end 12 and distal end 14together, or through the central longitudinally extending chamber of themesh). It is to be understood that such clearance would not exist asmesh 10 becomes anchored against walls 22 when positioned.

Following the step shown in FIG. 4, suture tethers 30 are preferablypulled in proximal direction P while proximal end 12 is held in a fixedposition relative to hole 21, (as shown in FIG. 5). When pulled bysuture/tethers 30, distal end 14 will tend to move in proximal directionP such that mesh 10 will expand radially in diameter in the region ofthe mesh pushing outwardly against the inner surface of hole 21, andforming a bulge 15 at mesh distal end 14 against inner surface 13.

Thereafter, as shown in FIG. 6, a rod 40, (which can be used to holdproximal end 12 in position relative to hole 21 while pulling on suturetethers 30 as illustrated in FIG. 5), can be used to push proximal end12 in distal direction D such that the region of mesh 10 betweenproximal end 12 and outer surface 11 will tend to expand around theproximal end of hole 21, forming a bulge 17 against outer surface 11, asshown. In this aspect of the invention, proximal end 12 may optionallybe formed to be non-expandable, for example by attachment to a fixeddiameter ring therearound.

The effect of mesh 10 being deformed to form respective bulges 17 and 15at the outer surface 11 and inner surface 13 of disc 20 will be to holdmesh 10 at a fixed longitudinal position relative to hole 21 (such thatit doesn't move in either a proximal or distal direction).

Thereafter, as shown in FIG. 7, proximal end 12 may optionally be pushedlongitudinally in distal direction D such that it passes through thecenter of the mesh such that it extends out through distal end 14. Inthis aspect of the invention, proximal end 12 may be formed to benon-expandable and have a slightly larger diameter than that of distalend 14 such that proximal end 12 can pass through distal end 14 and besnap-fit through the opening of distal end 14.

FIG. 8 is a perspective view of a system for delivering and positioningmesh 10 into hole 21 of the disc 20 as illustrated in FIGS. 1 to 7. Rod40 may be used to support proximal end 12 at a fixed position relativeto hole 21 when suture/tethers 30 are used to pull distal end 14 in aproximal direction. In addition, rod 40 can be used to push proximal end12 through distal end 14, as was shown in FIG. 7. Suture/tethers 30which may preferably comprise three tethers anchored to distal end 14 atlocations which are spaced radially 120° apart may be received over pushrod 40 as shown. A tubular inserter 35 is then received thereover.Inserter 35 may be used for pushing mesh 10 against the proximal end ofhole 21 as is shown in FIG. 6 so as to create bulge 17. Suture tethers30 may preferably be cut or removed after insertion.

In another aspect of the invention, as illustrated in FIGS. 9 and 10,each of the proximal and distal ends of the cylindrical mesh may bepulled inwardly towards the longitudinal center of the cylindrical meshsuch that the proximal end is moved distally and the distal end is movedproximally, as follows.

FIG. 9 shows a sectional elevation view of the mesh of FIG. 1 in a firstposition wherein distal end 14 has been pulled partially through thecenter of the cylindrical mesh 10 such that distal end 14 is receivedwithin the central body portion of mesh 10. Thereafter, as shown in FIG.10, proximal end 12 is then pushed partially through the center of thecylindrical mesh 10 such that proximal end 12 is also received withinthe central body portion of mesh 10.

In the aspect of the invention shown in FIGS. 9 and 10, mesh 10 willespecially tend to expand radially at outer surface 11 and inner surface13 close to ends 12 and 14 as shown. Expansion of mesh 10 in theseregions will cause formation of bulges immediately outside of the distaland proximal ends of hole 21 as shown. Such bulges will tend to anchorthe mesh such that it does not move longitudinally in hole 21. In theaspect of the invention shown in FIGS. 9 and 10, both proximal end 12and distal end 14 may optionally be covered by mesh or end caps sincethese ends need not pass through one another.

In this and the above discussed aspects of the invention, outward radialforces of the portions of the mesh which are curled within the main bodyof the mesh will preferably act against the outside walls of the outertube creating frictional loads along the longitudinal axis that farexceed the unfolding tendency of the mesh.

A further advantage of the present invention is that it may be adaptedto compensate for both thick or thin annular walls. For example, shouldthe length of hole 21 be slightly longer than the length of mesh 10,ends 12 and 14 will still be fully engaged within hole 21. Anotheradvantage of the present invention is that the exposed portions of themesh projecting out of hole 21 (e.g.: bulges 15 and 17) will beatraumatic, minimizing any potential irritation due to tissue contactdue to the soft and flexible nature of the mesh.

An alternate aspect of the first embodiment of the present invention isshown in FIGS. 11 to 12B, as follows. A mesh 50, (similar incharacteristics to mesh 10 as described above), is provided. As seen inthe cross sectional view of FIG. 12A, a suture/tether 52 runs fromdistal end 54 through the center of installation tube 60. As mesh 50 isadvanced distally into hole 21, as shown in FIG. 12B, it will form a“reversing funnel” shape with the outer edges of mesh 50 wrapping overthe body of the mesh inserted therethrough.

FIGS. 13A and 13B show respective front and side views of a seconddesign of the present invention in which device 100 comprises agenerally planar sheet of material which is cut or formed in a circularshape, having a plurality of radially extending “flower petal”extensions 102. These devices allow pressure equalization through theventing of lower viscosity fluids but retain higher viscosity fluids andsolids.

When inserted into a surgical access hole, petals 102 are first flexedradially inward in direction I. Accordingly, sheet 100 assumes agenerally conical shape when inserted into hole 21 in intervertebraldisc 20, as is shown in FIG. 14. After device 100 has been positioned inhole 21, (for example with a rod), petals 102 are released. Accordingly,petals 102 will tend to “spring back”, moving radially outwards indirection O such that petals 102 will press against the outer surfaces22 of hole 21 thereby anchoring device 100 in position in hole 21. Assuch, petals 102 act as cantilever leaf springs anchoring device 100 inposition in hole 21, thereby resisting outward (i.e. proximal) loadingdue to extruding nucleus pulposus.

As is shown in FIG. 15, optional barbs 104 may also be provided at thedistal ends of petals 102 to assist in anchoring petals 102 of device100 against walls 22 of hole 21. FIG. 15 shows a variety of alternatedesigns with differently shaped petals 102. FIG. 15 also shows anoptional design for a sheet 120 which does not have petals. Rather, sucha sheet is preferably crimped into a conical shape such that it can bepositioned in hole 21. Thereafter sheet 102 will expand (ie: flattenitself) to seal hole 21 with holes 121 allowing for fluid movementsimilar to the movement permitted between adjacent petals 102 as shownin other aspects of the invention.

Device 100 may preferably by formed to accommodate hole 21 having aninner diameter ranging from one-half to three quarters of the discdiameter in its free and flattened state. Device 100 can be formed fromwire or molded from plastic.

In preferred aspects, a plurality of devices 100 can be inserted intohole 21 in sequence as shown in FIG. 16. Such an arrangement has theadvantage of further restricting the movement of nucleus pulposus out ofthe center of disc 20. FIG. 17 corresponds to FIG. 16 but with theapexes 101 of devices 100 a and 100 b pointing in opposite directions.

FIGS. 18, 19 and 20 show successive steps in a method of insertingoppositely facing interlocking devices 100. Referring to FIG. 18, discs100 a and 100 b are first introduced into hole 21 (not shown) in anorientation such that their apexes 101 a and 101 b are pointing inopposite directions. A positioning rod 120 is used to push devices 100 aand 100 b together such that devices 100 a and 100 b become invertedsuch that their apexes 101 a and 101 b will be pushed together. As isseen in FIG. 20, apexes 101 a and 101 b can comprise interlockingfeatures such that they can be assembled to interlock together therebyforming a solid structure which tends to reduce radial movement of therespective apexes.

Experimentally Developed Embodiments:

The Applicants of the present invention have succeeded in constructingvarious experimental embodiments of the present invention, as follows.These experimental embodiments are meant to illustrate various exemplarysystems in accordance with the present invention. The present inventionis not limited to the experimental embodiments described herebelow.Rather, any suitable system for achieving the structures and methods ofthe present invention as claimed is considered within the scope of thepresent invention.

Mesh 10 of the present invention was experimentally constructed as abraided tube approximately 3 mm in diameter when in the relaxed state,and at least 9 mm in diameter when expanded. This tube was be braidedfrom 24 individual strands of 0.15 mm polypropylene suture.Alternatively, however, various numbers of strands may employed in thebraiding of the tube.

An experimental embodiment of mesh 10 was constructed from a 45 mmlength of braid which is cut and then placed over a heat resistantmandrel that just fits inside of the braid. The mandrel may preferablybe fabricated from a machineable ceramic. A 12 mm long stainless steeltube whose inside diameter just fits over the braid may be placed overthe braid/mandrel assembly with approximately 1 mm of braid exposed overthe mandrel. The braid/mandrel/tube assembly was then placed in a lathechuck or other machine capable rotating the assembly about it'slongitudinal axis in a controlled manner. The end of the braid was thenradiantly heated to just past the melting point of the braid polymer.The braid end was reformed to create a semi-rigid ring with in insidediameter of approximately equal to the original inside diameter of thebraid. By using this non contact method of forming using radiant heatand the fluidic surface tension of the re-flowing polymer, a robust andsmooth unitary ring was quickly formed. The whole assembly was thenremoved from the rotating machinery. The first mandrel was removed fromthe assembly and a second forming mandrel was inserted in it's place.The second forming mandrel was made of a machineable ceramic material,and one end of the mandrel being formed with a tapered bullet shapedtip. The bullet tip was placed even with the tapered tip at the end ofthe proximal end of the braid. The 12 mm long stainless steel tube wasthen placed over the braid/mandrel assembly with approximately 1 mm ofbraid exposed over the bullet tipped mandrel. The braid/mandrel/tubeassembly was again placed in the rotating machinery and slowly rotatedabout it's longitudinal axis. The proximal end of the braid was thenradiantly re-flowed to form a semi-rigid ring with an inside diameter ofapproximately one half to one quarter of the original braided diameter.The forming process described above can be accomplished in manydifferent ways using a variety of equipment and techniques.Alternatively, rings of non-native material may have instead beensecondarily added to the braided tube. The braid was then removed fromthe forming tools. A long piece of suture was then transversely passedthrough at least one braid intersection located near the distal end ofthe device. The tag ends of the suture are then brought together to forma loop with the device near the approximate center of the suture. Thisloop forming procedure is repeated twice more to form a system of threeequally spaced suture loops with a radial spacing of about 120° whenviewed from the end. The braid/loop assembly was then placed at thedistal end of a long rod or tube whose outside diameter will allow forthe longitudinal urging of the proximal end of the device and stillallow for diametral clearance of at least two wall thickness of thebraid material. The loops of suture were placed along side the length ofthe urging rod and arranged in a manner to prevent tangling of the tagends. A second long hollow tube with an outside diameter that allows forpassage into the surgical defect and inside diameter that allows for aslight diametral compression of the braid/loop assembly, is passed overthe braid/loop assembly until approximately 4 mm of braid is exposed. Itis to be understood that appropriate handles, grips and controls mayalso be added to the installation tool to enhance placement of thedevice and ease of use.

1. A method of sealing a hole in a body part, comprising: introducing agenerally cylindrical shaped mesh into the hole, the mesh having agenerally cylindrical shaped lumen extending between a proximal end anda distal end; and moving at least one of the proximal end and the distalend of the mesh at least partially into said lumen such that the meshexpands radially outwards against sides of the hole.
 2. The method ofclaim 1, wherein moving at least one end of the cylindrical shaped meshat least partially into the lumen comprises advancing the proximal endof the mesh in a distal direction.
 3. The method of claim 2, wherein theproximal end is advanced in a distal direction by a push rod.
 4. Themethod of claim 2, wherein the proximal end is advanced distally pastthe distal end.
 5. The method of claim 2, wherein the mesh bulges aroundthe perimeter of the proximal end of the hole and forms an ingressprevention element.
 6. The method of claim 1, wherein moving at leastone of the proximal and distal end of the mesh at least partially intothe lumen comprises advancing a distal end of the mesh in a proximaldirection.
 7. The method of claim 6 wherein the distal end is advancedproximally past the proximal end.
 8. The method of claim 6, wherein themesh bulges around the perimeter of the distal end of the hole and formsan egress prevention element.
 9. The method of claim 6, wherein thedistal end is advanced in a proximal direction by pulling on a tetherattached to the distal end of the mesh.
 10. The method of claim 1,wherein the cylindrical shaped mesh is introduced into the hole by:inserting a tubular inserter into the hole, wherein the mesh is receivedwithin a central bore of the tubular inserter; and withdrawing thetubular inserter from the hole while holding the mesh in the hole. 11.The method of claim 10, further comprising: pushing the proximal end ofthe mesh in a distal direction with a cylindrical inserter receivedwithin the tubular inserter.
 12. A method of sealing a hole in a bonystructure, comprising: introducing a generally cylindrical shaped meshinto the hole, the mesh having a generally cylindrical shaped lumenextending between a proximal end and a distal end; and moving at leastone of the proximal end and the distal end of the mesh at leastpartially into the lumen such that the mesh expands radially outwardsagainst sides of the hole to seal said hole in said bony structure. 13.A method of sealing a hole in a vertebral annulus, comprising:introducing a generally cylindrical shaped mesh into the hole; andmoving at least one end of the cylindrical shaped mesh at leastpartially into an interior portion of the cylindrical shaped mesh suchthat the mesh expands radially outwards against sides of the hole toseal said hole in said vertebral annulus.
 14. A method of sealing a holein a body, comprising: introducing a generally cylindrically shaped meshinto the hole, the mesh having a generally cylindrical shaped lumenextending between a proximal end and a distal end; and pushing aproximal end of the mesh at least partially into the lumen such that themesh expands radially outwards against the sides of the hole.
 15. Amethod of sealing a hole in a body, comprising: introducing a generallycylindrically shaped mesh into the hole, the mesh having a generallycylindrically shaped lumen extending between a proximal end and a distalend; and pulling the distal end of the mesh at least partially back intothe lumen such that the mesh expands radially outwards against the sidesof the hole.